EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium

Vaccine. 2008 Jun 13;26(25):3153-61. doi: 10.1016/j.vaccine.2008.03.083. Epub 2008 May 27.

Abstract

NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag, pol, env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA-NYVAC-C comparison to NYVAC-C alone.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS Vaccines / administration & dosage*
  • AIDS Vaccines / chemistry
  • AIDS Vaccines / immunology*
  • Adult
  • Female
  • HIV Infections / prevention & control
  • HIV-1 / immunology
  • Humans
  • Male
  • Middle Aged
  • Peptides / chemistry
  • Viral Vaccines / administration & dosage*
  • Viral Vaccines / chemistry
  • Viral Vaccines / immunology*
  • Viral Vaccines / therapeutic use

Substances

  • AIDS Vaccines
  • NYVAC vaccine
  • Peptides
  • Viral Vaccines